ArticlemAbs
An evaluation of instrument types for mass spectrometry-based multi-attribute analysis of biotherapeutics.
Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed.
- Development and Integrated Application of the Multi-Attribute Method (MAM) in Quality Control of Biotechnological Drugs.Biotechnology and bioengineering · 2026Review
- Protein Therapeutic Quality Control Using Multi-Attribute Method (MAM): Challenges and Current Practice in cGMP Environments.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Artificial Oxidation: A Major Challenge in Implementing Multi-Attribute Methods for Therapeutic Protein Analysis.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Multi-attribute monitoring (MAM) methodology for glycosylated subunit vaccines.Scientific reports · 2025Article
- A Multi-Laboratory, Multi-Platform Analysis of the Multi-Attribute Method.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Article
- Multi-Attribute Monitoring Method for Process Development of Engineered Antibody for Site-Specific Conjugation.Journal of the American Society for Mass Spectrometry · 2023Article
- Automated Retrieval of Heterogeneous Proteomic Data for Machine Learning.Journal of personalized medicine · 2023Article
- Comprehensive multi-attribute method workflow for biotherapeutic characterization and current good manufacturing practices testing.Nature protocols · 2023Review
- Engineering protein glycosylation in CHO cells to be highly similar to murine host cells.Frontiers in bioengineering and biotechnology · 2023Article
- Development of a comprehensive approach for performance evaluation of a quantitative multi-attribute method as a quality control method.Analytical sciences : the international journal of the Japan Society for Analytical Chemistry · 2022Article
- Multi attribute method implementation using a High Resolution Mass Spectrometry platform: From sample preparation to batch analysis.PloS one · 2022Article
- Interlaboratory Studies Using the NISTmAb to Advance Biopharmaceutical Structural Analytics.Frontiers in molecular biosciences · 2022Review
- Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Multi-attribute methods (MAM), based on proteolytic digestion followed by liquid chromatography-mass spectrometry analysis of proteolytic peptides, have gained substantial attention in the biopharmaceutical industry for quantifying a variety of quality attributes for therapeutic proteins. Most MAM developed so far have been based on high-resolution mass spectrometers, due to their superb resolving power to distinguish analyte signals from interferences. Lower-resolution instruments, if demonstrated suitable, may further promote the adoption of the technology due to their low cost, small footprint, and ease of use. In this work, we compared the performance of a high-resolution instrument with a few low-resolution quadrupole-type instruments in quantifying a diverse set of quality attributes in a monoclonal antibody product. Different modes of operation for the quadrupole instruments, including scan mode, selected-ion monitoring and multiple-reaction monitoring, were evaluated. The high-resolution instrument has superb performance, with a quantitation limit of 0.002%. Single-quadrupole instruments in scan mode, on the other hand, provide a quantitation limit of about 1%, which may be fit-for-purpose for many routine MAM applications.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.